PERSONA™ Natural Tibia™ 42-5321-079-01

GUDID 00889024246911

Zimmer, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00889024246911
• NIH Device Record Key: ec6c13b0-b5db-497e-880b-7f047e1b864e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONA™ Natural Tibia™
• Version Model Number: 42-5321-079-01
• Catalog Number: 42-5321-079-01
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024246911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113369

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

[00889024246911]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-14
• Device Publish Date: 2016-05-30

On-Brand Devices [PERSONA™ Natural Tibia™]

• 00889024246966: 42-5321-088-02
• 00889024246959: 42-5321-088-01
• 00889024246942: 42-5321-083-02
• 00889024246935: 42-5321-083-01
• 00889024246928: 42-5321-079-02
• 00889024246911: 42-5321-079-01
• 00889024246904: 42-5321-075-02
• 00889024246898: 42-5321-075-01
• 00889024246881: 42-5321-071-02
• 00889024246874: 42-5321-071-01
• 00889024246867: 42-5321-067-02
• 00889024246850: 42-5321-067-01
• 00889024246843: 42-5321-064-02
• 00889024246836: 42-5321-064-01
• 00889024246645: 42-5320-061-02
• 00889024246638: 42-5320-061-01
• 00889024246621: 42-5320-058-02
• 00889024246614: 42-5320-058-01
• 00889024471146: 42-5320-088-02
• 00889024471139: 42-5320-088-01
• 00889024471122: 42-5320-083-02
• 00889024471085: 42-5320-075-02
• 00889024471054: 42-5320-071-01
• 00889024471047: 42-5320-067-02
• 00889024471016: 42-5320-064-01
• 00889024246782: 42-5320-088-02
• 00889024246775: 42-5320-088-01
• 00889024246768: 42-5320-083-02
• 00889024246751: 42-5320-083-01
• 00889024246744: 42-5320-079-02
• 00889024246737: 42-5320-079-01
• 00889024246720: 42-5320-075-02
• 00889024246713: 42-5320-075-01
• 00889024246706: 42-5320-071-02
• 00889024246690: 42-5320-071-01
• 00889024246683: 42-5320-067-02
• 00889024246676: 42-5320-067-01
• 00889024246669: 42-5320-064-02
• 00889024246652: 42-5320-064-01
• 00889024471115: 42-5320-083-01
• 00889024471108: 42-5320-079-02
• 00889024471092: 42-5320-079-01
• 00889024471078: 42-5320-075-01
• 00889024471061: 42-5320-071-02
• 00889024471030: 42-5320-067-01
• 00889024471023: 42-5320-064-02
• 00889024246829: 42-5321-061-02
• 00889024246812: 42-5321-061-01
• 00889024246805: 42-5321-058-02
• 00889024246799: 42-5321-058-01